Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ROMFLEX REHABILITATION EQUIPMENT

K-Number: K905299 · 1990-12-31

ApplicantDyna Flex, Intl.
Decision Date1990-12-31
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ROMFLEX REHABILITATION EQUIPMENT is the device name listed in this FDA 510(k) record. The listed applicant is Dyna Flex, Intl.. It received FDA 510(k) clearance on 1990-12-31 under 510(k) number K905299. The device is classified under product code BXB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROMFLEX REHABILITATION EQUIPMENT?

ROMFLEX REHABILITATION EQUIPMENT is a medical device that received FDA 510(k) clearance on 1990-12-31. The listed applicant is Dyna Flex, Intl.. The 510(k) number is K905299.

When did ROMFLEX REHABILITATION EQUIPMENT receive FDA 510(k) clearance?

ROMFLEX REHABILITATION EQUIPMENT received FDA 510(k) clearance on 1990-12-31, under 510(k) number K905299.

Who is the listed applicant for ROMFLEX REHABILITATION EQUIPMENT?

The FDA 510(k) record lists Dyna Flex, Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROMFLEX REHABILITATION EQUIPMENT?

The FDA product code for ROMFLEX REHABILITATION EQUIPMENT is BXB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Dyna Flex, Intl. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K910150ROMFLEX REHAB EQUIP EXTREMITIES UNITK910149ROMFLEX REHAB EQUIP LATERAL FLEXION UNITK910151ROMFLEX REHAB EQUIP CERVICAL FLEXOR UNIT

Related Devices (Code: BXB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K072887G-TRAINER MEDICALAlter-G, Inc.K003272FLO-BOOTDiscovery Group, LLCK952975ANKLE CALF EXERCISER PHLEBOPUMPPrevent Products, Inc.K953456E-Z FLEXFluid Motion Biotechnologies, Inc.K955106BTE CPM-20Baltimore Therapeutic Equipment Co.K955105BTE CPM-10Baltimore Therapeutic Equipment Co.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑